Design and 3D printing of a modular phantom of a uterus for medical device validation

Abstract

Purpose The purpose of this study is to describe the design and validation of a three-dimensional (3D)-printed phantom of a uterus to support the development of uterine balloon tamponade devices conceived to stop post-partum haemorrhages (PPHs). Design/methodology/approach The phantom 3D model is generated by analysing the main requirements for validating uterine balloon tamponade devices. A modular approach is implemented to guarantee that the phantom allows testing these devices under multiple working conditions. Once finalised the design, the phantom effectiveness is validated experimentally. Findings The modular phantom allows performing the required measurements for testing the performance of devices designed to stop PPH. Social implications PPH is the leading obstetric cause of maternal death worldwide, mainly in low- and middle-income countries. The proposed phantom could speed up and optimise the design and validation of devices for PPH treatment, reducing the maternal mortality ratio. Originality/value To the best of the authors’ knowledge, the 3D-printed phantom represents the first example of a modular, flexible and transparent uterus model. It can be used to validate and perform usability tests of medical devices.

A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings

“…The intraluminal pressure (ILP) is the pressure inside the balloon, evaluated as a function of the filling volume and the external conditions, i.e., the environment in which the balloon inflates. As discussed in a previous paper 31 , this pressure also depends on the stiffness of the material the balloon is made of. Reference values for UBT solutions based on the use of condoms/probe covers can be found in 23 and refer again to the mechanical characterisation of the ESM.…”

“…( b) Intraluminal pressure measurement in open air condition. ( c-d ) Intraluminal pressure measurement in confined conditions: a commercial uterus model ( c ) and an ad hoc 3D-printed uterus phantom ( d ) 31 . The setups in b-d comprise a 500 ml syringe, a water reservoir, a pressure transducer, and a 3-way stopcock for tubing connections.…”

“…This value corresponds to the volume of the internal cavity of the commercial uterus. Details about the 3D-printed phantom can be found in a previous work 31 . Compared to the commercial simulator, the 3D-printed uterus is bigger and has an internal cavity of approximately 2500 ml.…”

“…Compared to the commercial simulator, the 3D-printed uterus is bigger and has an internal cavity of approximately 2500 ml. It comprises a single uterus body that can be assembled with three interchangeable cervices, characterised by different dilations (see 31 and Supplementary Fig. S1 a).…”

“…The “medium size” cervix was used for the tests, corresponding to a dilation of 50 mm 31 . The phantom is equipped with a reclinable support to mimic three physiological inclinations of the uterus during childbirth (see 31 and Supplementary Fig. S1 b).…”